Risedronate Sodium

Orange BookUNIISPLATC M05BA07

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeM05BA07

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093309956
30 TABLET, FILM COATED in 1 BOTTLE (0093-3099-56)

Annotations

UNII (FDA Substance ID)

F67L43UT5C

RISEDRONATE SODIUM MONOHYDRATE

RxCUI 1356128

Orange Book

A077132

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "F67L43UT5C",
    "rxcui": "1356128",
    "inchikey": "KLQNARDFMJRXSF-UHFFFAOYSA-M",
    "display_name": "RISEDRONATE SODIUM MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "c89430be-15f1-4b8b-ab7e-738de716ee7d": {
      "match": "brand_token",
      "title": "RISEDRONATE SODIUM TABLET, DELAYED RELEASE [MYLAN PHARMACEUTICALS, INC.]",
      "spl_version": "7",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0093-3099_641c2a59-be2b-4246-8990-b7bf563012be",
  "productndc": "0093-3099",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "077132",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "5MG",
        "product_no": "001",
        "approval_date": "Oct 5, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "30MG",
        "product_no": "002",
        "approval_date": "Oct 5, 2007"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "35MG",
        "product_no": "003",
        "approval_date": "Oct 5, 2007"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RISEDRONATE SODIUM MONOHYDRATE",
  "proprietary_name": "Risedronate Sodium",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA077132",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Risedronate Sodium",
  "start_marketing_date": "20150601",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code M05BA07.

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